PREVACID
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PREVACID (PREVACID).
Proton pump inhibitor (PPI) that irreversibly inhibits the H+/K+ ATPase enzyme (proton pump) in gastric parietal cells, thereby suppressing gastric acid secretion.
| Metabolism | Primarily metabolized by hepatic CYP2C19 and CYP3A4 isoenzymes to inactive metabolites. |
| Excretion | Renal (approx. 70% as metabolites), fecal (approx. 30% as metabolites). Less than 1% excreted unchanged in urine. |
| Half-life | Terminal elimination half-life is approximately 1.5 hours. No significant accumulation with once-daily dosing. |
| Protein binding | Approximately 97% bound to plasma proteins, mainly albumin. |
| Volume of Distribution | Volume of distribution is about 0.25 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Oral bioavailability is about 80% (range 70-85%) for the delayed-release capsule; intravenous bioavailability is 100%. |
| Onset of Action | Oral: 1-2 hours for acid suppression; maximal effect within 2-4 hours. |
| Duration of Action | Duration of acid suppression is up to 24 hours, allowing once-daily dosing for most indications. |
| Action Class | Proton pump inhibitors |
| Brand Substitutes | Pantoride 40 Tablet, Topp 40 Tablet, Panplus 40 Tablet, Pancare 40mg Tablet, Aciban 40 Tablet, Panfirst 40mg Injection, Troypanto 40mg Injection, Zepoxin 40mg Injection, P-Ppi Injection, Pantodac IV Injection |
15-30 mg orally once daily; or 30 mg orally twice daily for severe GERD.
| Dosage form | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
| Renal impairment | No dosage adjustment required for any degree of renal impairment. |
| Liver impairment | For Child-Pugh Class A and B: no adjustment; Class C: reduce dose to 15 mg daily. |
| Pediatric use | 1-11 years: 15 mg daily if ≤30 kg, 30 mg daily if >30 kg; 12-17 years: 15-30 mg daily. |
| Geriatric use | No specific adjustment; monitor renal function and avoid doses >30 mg/day in elderly due to increased exposure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PREVACID (PREVACID).
| Breastfeeding | Lansoprazole is excreted in human milk. M/P ratio not established. However, due to low oral bioavailability in infants and lack of adverse effects reported, it is considered compatible with breastfeeding; caution is advised. |
| Teratogenic Risk | FDA Pregnancy Category B. Animal studies showed no evidence of harm, but no adequate human studies. First trimester: limited data suggests no increased risk of major malformations. Second and third trimesters: no known fetal risks, but use only if clearly needed due to potential for hypochlorhydria affecting maternal absorption of nutrients. |
■ FDA Black Box Warning
No FDA black box warnings.
| Serious Effects |
["Hypersensitivity to lansoprazole or any PPI","concurrent use with rilpivirine-containing products","severe hepatic impairment (child-Pugh class C, not recommended)"]
| Precautions | ["Long-term use (especially >1 year) may increase risk of Clostridium difficile infection","osteoporosis-related fractures","hypomagnesemia","vitamin B12 deficiency","acute interstitial nephritis","lupus erythematosus","gastric fundic gland polyps"] |
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| Fetal Monitoring | Monitor for gastric acid suppression effects; no specific fetal monitoring required. In prolonged use, consider monitoring maternal vitamin B12 levels due to risk of deficiency from long-term hypochlorhydria. |
| Fertility Effects | No known significant effects on human fertility. Animal studies showed no impairment of fertility at clinically relevant doses. |